Last month, FDA published two draft guidances:
– “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities”;
– “Medical Product Communications That Are Consistent With the FDA- Required Labeling”.
Scope of these FAQ documents is to regulate ways and contents of communication in the medical field.
The first document, for medical products not yet approved by FDA, is about the communication of Health care economic information (HCEI) to the users and describes the accuracy and truthfulness requirements to be followed by the Manufacturers.
The “Medical Product Communications That Are Consistent With the FDA- Required Labeling” draft guidance refers to Medical Devices already cleared by a PMN (Pre-market Notification – 510(K)) or a PMA (Pre-Market Approval). The aim of this document is to assess the consistency between the already reviewed information on the labelling and the promotional texts (for example: advertising), not previously controlled by the FDA.
At the moment, the guidelines are on public consultation. Comments can be submitted by April 2017.
For further information:
